Senior Statistician

The Principal Statistician is responsible for providing statistical expertise and strategic thinking to quantify the Benefit, Risk, Value and Uncertainty of the emerging product profile. They lead the statistical thinking and quantitative contributions for all aspects of the development process.

Accountabilities/Responsibilities:

•Delivery of strategic input, either in a specific therapeutic area or area of expertise.

•Provision of statistical support and leadership to project teams.

•Define and lead analysis of relevant internal and external information to inform design decisions (e.g. evaluation of biomarkers as potential diagnostics for a PHC approach, evaluation of potential outcome measures, meta analysis of data to provide characteristics to define non-inferiority criteria)

•Develop design options that address cost time uncertainty and probability of success with the appropriate use of modeling and simulation or other techniques to enable the business to make informed decisions.

•Provide expert statistical thinking to support interpretation and decision-making processes (e.g. tollgate decisions, labeling),

•Application of expert statistical skills to provide support to the regulatory submissions including specification and construction of overview documents, responses to regulatory questions, and representation at Health Authority interactions.

•Providing specifications and direction to outsourcing partners/providers to ensure clarity and appropriateness of specifications and standards, early resolution of emerging issues. They hold partners and providers accountable for the quality of their deliverable.

Education and Experience:

•Essential – MS/MSc in Statistics or Medical Statistics.

•Substantial experience at Senior Statistician or equivalent level